Safety and Effects of Ramipril Combined With Candesartan

This study has been completed.

First Received: July 25, 2006 No Changes Posted

Sponsor:	Gachon University Gil Medical Center
Information provided by:	Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:	NCT00356395

Purpose

we hypothesized that combination therapy has additive beneficial effects to improve endothelial dysfunction and adipocytokine profiles in patients with hypertension.

Condition	Intervention	Phase
Hypertension	Drug: ramipril, candesartan	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Cardiovascular and Metabolic Effects of Combination Therapy With Ramipril and Candesartan In Hypertensive Patients

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Ramipril CV 11974 Candesartan cilexetil

U.S. FDA Resources

Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:

comparison of endothelium-dependent dilation among the 3 treatment schemes

Estimated Enrollment:	40
Study Start Date:	August 2003
Estimated Study Completion Date:	March 2006

Detailed Description:

Forty patients will be given ramipril 10 mg and placebo, ramipril 10 mg and candesartan 16 mg, or candesartan 16 mg and placebo daily in a randomized, double-blind, placebo-controlled cross-over trial with three treatment arms and two washout periods (each 2 months).

Eligibility

Ages Eligible for Study:	35 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients with mild to moderate hypertension

Exclusion Criteria:

We will exclude patients with severe hypertension, unstable angina, acute myocardial infarction, or renal insufficiency.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356395

Sponsors and Collaborators

Gachon University Gil Medical Center

Investigators

Principal Investigator:

Kwang K Koh, MD

Cardiology, Gil Heart Center, Gachon Medical School

More Information

No publications provided

Study ID Numbers:	2003-008
Study First Received:	July 25, 2006
Last Updated:	July 25, 2006
ClinicalTrials.gov Identifier:	NCT00356395 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Gachon University Gil Medical Center:

endothelial function, insulin resistance, adipocytokines

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Ramipril
Pharmacologic Actions
Protease Inhibitors

Angiotensin II Type 1 Receptor Blockers
Candesartan cilexetil
Therapeutic Uses
Candesartan
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010